Soft, chewable and orally dissolvable and/or disintegrable products

ABSTRACT

A soft, chewable and orally dissolvable and/or disintegrable product includes a biopolymer-sugar based matrix and botanical powder dispersed throughout the biopolymer-sugar based matrix. The biopolymer-sugar based matrix includes at least one biopolymer, at least one sugar and optional additives. Soft, chewable and orally dissolvable and/or disintegrable product can also include flavor beads.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/276,969, filed Feb. 15, 2019, which is a continuation application ofU.S. patent application Ser. No. 14/856,673, filed Sep. 17, 2015, whichis a divisional application of U.S. application Ser. No. 12/633,247,filed Dec. 8, 2009, issued as U.S. Pat. No. 9,155,772 on Oct. 13, 2015,which claims priority to U.S. Provisional Application No. 61/193,574,filed Dec. 8, 2008, the entire content of each of which is incorporatedherein by reference.

SUMMARY

A soft, chewable and orally dissolvable and/or disintegrable productcomprising a biopolymer-sugar based matrix and botanical powder in anamount sufficient to form at least about 30 wt % to about 75 wt % of thesoft, chewable and orally dissolvable product is provided. Thebiopolymer-sugar based matrix comprises at least one biopolymer in anamount of about 1 to about 35 wt % of the soft, chewable and orallydissolvable product and at least one sugar in an amount of about 2 wt %to about 60 wt % of the soft, chewable and orally dissolvable and/ordisintegrable product. The soft, chewable and orally dissolvable and/ordisintegrable product is chewable in a user's mouth for about 3 minutesto about 10 minutes before dissolving and disintegrating in an oralcavity of a user. Also, the at least one sugar is included in an amountsufficient to substantially inhibit cross-linking between the at leastone botanical powder and the at least one biopolymer.

In an embodiment, the soft, chewable and orally dissolvable and/ordisintegrable product can also include flavor beads to add additionaltexture and flavor to the soft, chewable and orally dissolvable and/ordisintegrable product. The flavor beads can include a polymer coating.The polymer coating can be abrasive. Preferably, the beads havediameters of about 0.5 mm to about 4.0 mm.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of an embodiment of a soft, chewable andorally dissolvable and/or disintegrable product comprising abiopolymer-sugar based matrix and botanical powder.

FIG. 2 is an illustration of an embodiment of a soft, chewable andorally dissolvable and/or disintegrable product comprising abiopolymer-sugar based matrix, a botanical powder and flavor beads.

FIG. 3 is an illustration of an embodiment of a soft, chewable andorally dissolvable and/or disintegrable product comprising abiopolymer-sugar based matrix, a botanical powder and flavor beads.

DETAILED DESCRIPTION

As shown in FIG. 1 , a soft, chewable and orally dissolvable and/ordisintegrable product 10 comprises a biopolymer-sugar based matrix andat least one botanical powder. Preferably, the biopolymer-sugar basedmatrix includes at least one biopolymer, which acts as a binder, and atleast one sugar, which acts as a co-binder. In the preferred embodiment,the botanical powder is tobacco powder. Preferably, the soft, chewableand orally dissolvable and/or disintegrable product can be chewed by auser until substantially all of the ingredients contained thereinsubstantially dissolve and disintegrate in the user's mouth.

In the preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product 10 is free of animal products, such asgelatin. Preferably, animal products, such as gelatin, are not includedin the matrix so as to prevent hardening of the matrix prior to use. Inaddition, by not including gelatin and/or other animal products, thesoft, chewable and orally dissolvable and/or disintegrable product isacceptable for use by vegans, users with allergies, and/or users withcultural and religious beliefs, which discourage consumption of animalproducts. In addition, the lack of animal products in the soft, chewableand orally dissolvable and/or disintegrable product 10 prevents thetransmission of possible diseases associated with animal tissues, suchas bovine spongiform encephalopathy. In a preferred embodiment, thesoft, chewable and orally dissolvable and/or disintegrable product 10can also be organic.

In the preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product does not include synthetic softeners,plasticizers or proteins (e.g., gelatin, rice protein, soy proteinand/or corn zein). However, a softener and/or plasticizer, such asglycerin, can optionally be used to add additional softness to thebiopolymer-sugar based matrix. Such softeners and/or plasticizers areunnecessary due to the use of the co-binder, which acts to inhibitcross-linking between the biopolymer binder and the botanical powder andresulting hardness.

As used herein, the terms “soft,” “soften” and “softness” describes thesoft, chewable and orally dissolvable and/or disintegrable productcontaining botanical powder in a relatively malleable state. Preferably,the product is firm, but not hard.

Preferably, the soft, chewable and orally dissolvable and/ordisintegrable product 10 includes at least one biopolymer in an amountof about 1 wt % to about 35 wt %, more preferably about 2 wt % to about20 wt % (e.g., about 2 wt % to about 5 wt %, about 5 wt % to about 10 wt%, about 10 wt % to about 15 wt % or about 15 wt % to about 20 wt %).

Suitable biopolymers include, without limitation, agar, alginate,carrageenans, such as iota carrageenan and kappa carrageenan, cellulose,gellan gum, guar gum, gum Arabic, konjac gum, locust bean gum, modifiedstarch, pectin, xanthan gum, and/or combinations thereof. Preferably,the biopolymer does not comprise a protein, such as corn zein, riceprotein, soy protein and/or gelatin.

In the preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product 10 also includes a sugar. Preferably, thesugar provides both softening and sweetening of the soft, chewable andorally dissolvable and/or disintegrable product. Also preferably, thesugar is included in an amount of about 2 wt % to about 60 wt %, morepreferably about 5 wt % to about 30 wt % (e.g., about 5 wt % to about 25wt %, about 10 wt % to about 20 wt %, about 15 wt % to about 20 wt %,about 20 wt % to about 25 wt % or about 15 wt % to about 30 wt %).

In the preferred embodiment, the matrix does not harden even withprolonged exposure to air. Not wishing to be bound by theory, it isbelieved that the sugar forms hydrogen bonds with the biopolymer andblocks binding sites thereof to prevent cross-linking between thebiopolymer and the botanical powder (e.g., tobacco, which is chemicallyactive). By preventing cross-linking between the biopolymer and thetobacco, the soft, chewable and orally dissolvable and/or disintegrableproduct maintains a soft consistency as compared to oral products thatcontain cross-linked polymers. Thus, if less than 2 wt % sugar is used,not all of the active sites of the biopolymer will be blocked, therebyallowing some cross-linking to occur, which results in the formation ofa harder matrix. Alternatively, if sugar is used in larger amounts theactive sites of the biopolymer will be completely blocked to form a softproduct, and any excess sugar will act to sweeten the soft, chewable andorally dissolvable product.

Preferred sugars are small molecule saccharides, such as honey and/orhigh fructose corn syrup. However, other suitable sugars include,without limitation, monosaccharides (e.g., fructose, glucose, xylose,etc.), disaccharides (e.g., sucrose, trehalose, lactose, etc.),trisaccharides, polysaccharides, oligosaccharides (e.g., fructan andinulins), sugar alcohols (e.g., sorbitol, xylitol, lactitol, maltitol,etc.), and mixtures of sugars (e.g., combinations of honey, corn syrups,light corn syrups and/or high fructose corn syrups, etc.). Additionally,sweeteners, such as sucralose can be used.

Also preferably, the soft, chewable and orally dissolvable and/ordisintegrable product 10 optionally includes at least one additive.Suitable additives include, without limitation, vitamins, minerals,nutraceuticals, energizing agents, soothing agents, coloring agents,amino acids, chemesthesis agents, antioxidants, flavorants, food gradeemulsifiers, pH modifiers, and/or combinations thereof. The additivescan be included in the soft, chewable and orally dissolvable product 10in an amount of up to about 10 wt % (e.g., about 1 wt % to about 5 wt %or about 5 wt % to about 10 wt %).

Suitable soothing agents include, without limitation, chamomile,lavender, jasmine, and the like.

Suitable energizing ingredients include, without limitation, caffeine,taurine, and guarana.

Suitable vitamins include, without limitation, vitamin A (retinol),vitamin D (cholecalciferol), vitamin E group, vitamin K group(phylloquinones and menaquinones), thiamine (vitamin B₁), riboflavin(vitamin B₂), niacin, niacinamide, pyridoxine (vitamin B₆ group), folicacid, choline, inositol, vitamin B₁₂ (cobalamins), PABA(para-aminobezoic acid), biotin, vitamin C (ascorbic acid), and mixturesthereof. The amount of vitamins incorporated into soft, chewable andorally dissolvable and/or disintegrable product can be varied accordingto the type of vitamin and the intended user of the soft, chewable andorally dissolvable and/or disintegrable product. For example, the amountof vitamins may be formulated to include an amount less than or equal tothe recommendations of the United States Department of AgricultureRecommended Daily Allowances.

The chemesthesis ingredients can provide, without limitation, hot,spicy, or cooling flavors. Suitable chemesthesis agents include, withoutlimitation, capsaicin, tannins, mustard oil, wintergreen oil, cinnamonoil, allicin, quinine, citric acid, and salt.

As used herein, the term “nutraceuticals” refers to any ingredient infoods that has a beneficial effect on human health. Nutraceuticalsinclude particular compounds/compositions isolated from natural foodsources and genetically modified food sources. For example,nutraceuticals include various phytonutrients derived from naturalplants and genetically engineered plants.

Suitable minerals include, without limitation, calcium, magnesium,phosphorus, iron, zinc, iodine, selenium, potassium, copper, manganese,molybdenum, chromium, and mixtures thereof. The amount of mineralsincorporated into the soft, chewable and orally dissolvable and/ordisintegrable product can be varied according to the type of vitamin andthe intended user. For example, the amount of minerals may be formulatedto include an amount less than or equal to the recommendations of theUnited States Department of Agriculture Recommended Daily Allowances.

Suitable amino acids include, without limitation, the eight essentialamino acids that cannot be biosynthetically produced in humans,including valine, leucine, isoleucine, lysine, threonine, tryptophan,methionine, and phenylalanine. Examples of suitable amino acids includethe non-essential amino acids including alanine, arginine, asparagine,aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine,proline, serine, and tyrosine.

In another embodiment, the soft, chewable and orally dissolvable and/ordisintegrable product 10 can include various active agents havingantioxidant properties that can delay the ageing process, as food-gradeingredients. For example, the active ingredients that can be extractedfrom Ginkgo biloba include flavonoid glycosides (“ginkgoflavonoids”),such as (iso)quercitin, kaempferol, kaempferol-3-rhamnosides,isorhamnetin, luteolin, luteolin glycosides, sitosterol glycosides, andhexacyclic terpene lactones, referred to as “ginkgolides” or“bilobalides.” The active ingredients that can be extracted fromCamellia sinensis, such as green tea, include various “tea tannins,”such as epicatechol, epigallocatechol, epigallocatechol gallate,epigallocatechol gallate, theaflavin, theaflavin monogallate A or B, andtheaflavin digallate. The active ingredients that can be extracted fromVaccinium myrtillus, such as blueberry, include at least 15 differentanthocyanosides, such as delphinidin, anthocyanosides, myrtin,epimyrtin, phenolic acids, glycosides, quercitrin, isoquercitrin, andhyperoside. The active ingredients that can be extracted from Vinisvitifera, such as grapes, include polyphenols, catechols, quercitrins,and resveratrols. The active ingredients that can be extracted from Oleaeuropensis, such as the leaves of olive trees, include oleuropein. Manyactive ingredients identified from these and other plant sourcesassociated with the neutralization of free radicals and useful fordelaying the ageing process are contemplated. Other antioxidants knownin the art are also contemplated.

The active ingredients of Trifolium pratense, such as purple clovers(i.e., common purple trefoils), include isoflavones or isoflavoneglucosides, daidzein, genestein, formononentin, biochanin A, ononin, andsissostrin. The health-promoting properties of compounds derived fromPanax, a genus that includes Ginseng, are well-established. These andother botanticals, botanical extracts, and bioactive compounds havinghealth promoting effects are contemplated.

The botanical extracts may be prepared by various methods known in theart, including maceration, remaceration, digestion, agitationmaceration, vortex extraction, ultrasonic extraction, countercurrentextraction, percolation, repercolation, evacolation, diacolation, andsolid/liquid extraction under continuous reflux.

Suitable flavorants include any flavorants commonly used in foods,confections, oral products and/or tobacco articles. Exemplary flavorantsinclude, but are not limited to, berry flavors such as pomegranate,acai, raspberry, blueberry, strawberry, boysenberry, and/or cranberry.Other suitable flavorants include, without limitation, any natural orsynthetic flavor or aroma, such as menthol, peppermint, spearmint,wintergreen, bourbon, scotch, whiskey, cognac, hydrangea, lavender,chocolate, licorice, citrus and other fruit flavors, such as apple,peach, pear, cherry, plum, orange, lime, grape, and grapefruit, gammaoctalactone, vanillin, ethyl vanillin, breath freshener flavors, butter,rum, coconut, almond, pecan, walnut, hazelnut, French vanilla,macadamia, sugar cane, maple, cassis, caramel, banana, malt, espresso,kahlua, white chocolate, spice flavors such as cinnamon, clove,cilantro, basil, oregano, garlic, mustard, nutmeg, rosemary, thyme,tarragon, dill, sage, anise, and fennel, methyl salicylate, linalool,jasmine, coffee, olive oil, sesame oil, sunflower oil, bergamot oil,geranium oil, lemon oil, ginger oil, balsamic vinegar, rice winevinegar, and red wine vinegar.

The flavorants can be incorporated in the matrix or applied to the soft,chewable and orally dissolvable and/or disintegrable product 10 byspraying, coating, immersing, embossing, and/or dispersing them into oronto the soft, chewable and orally dissolvable product itself. In anembodiment, the flavorants are added in the form of spray driedflavorants, essential oils, and/or solutions. In other embodiments, theflavorants can be added to the biopolymer solution during formation ofthe soft, chewable and orally dissolvable product.

Suitable pH modifiers include, without limitation, Na₂CO₃, NaHCO₃,K₃PO₄, K₃HPO₄, NaOH, HCl, citric acid and combinations thereof. pHmodifiers can be added to adjust the flavor of the soft, chewable andorally dissolvable and/or disintegrable product 10. Since some polymerstend to be acidic by nature, a pH modifier can be included to neutralizethe taste of the soft, chewable and orally dissolvable product 10.Preferably, the soft, chewable and orally dissolvable and/ordisintegrable product 10 has a pH of about 5 to about 8, more preferablyabout 7 to about 8. A pH less than about 5 tends to be too sour.

In an embodiment, the soft, chewable and orally dissolvable and/ordisintegrable product 10 can include a food-grade emulsifier.Preferably, the food-grade emulsifier is added when oil basedflavorants, such as wintergreen oil, are included in the soft, chewableand orally dissolvable product 10 to stabilize the flavorant within thehydrocolloid based matrix. Typically, food-grade emulsifiers are notnecessary for use with water based flavorants. However, food-gradeemulsifiers can be used with water based flavorants if desired. Suitablefood-grade emulsifiers include, without limitation, phospholipids, suchas lecithins, fatty acid mono- and di-glycerides, phosphatedmonoglycerides, glycerol esters, such as glycerol monooleate, glycerolmonotallate, polyglycerol oleate and/or polyglycerol decaoleate,sorbitan esters, such as sorbitan monolaurate, sorbitan monostearate,sorbitan monooleate and/or sorbitan trioleate, and/or polysorbates(e.g., Polysorbate 20 and/or Polysorbate 80).

In the preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product 10 includes at least one botanical powderin an amount of up to about 75 wt % by weight based on the weight of thesoft, chewable and orally dissolvable product, more preferably about 30wt % to about 75 wt % (e.g., about 45 wt % to about 55 wt %, about 55 wt% to about 65 wt % or about 65 wt % to about 75 wt %). Preferably, iftobacco powder is used, the tobacco powder is included in an amount ofat least about 50 wt %. Suitable botanical powders can include teapowder, tobacco powder, coffee powder, herbal powders, spice powdersand/or combinations thereof. Preferably, the botanical powder is derivedfrom any botanical material that has a surface chemistry with functionalgroups (e.g., phenolics) that cross-link proteins and biopolymers. Alsopreferably, the soft, chewable and orally dissolvable and/ordisintegrable product 10 includes a majority amount of the botanicalpowder to increase flavor delivery thereof. In a preferred embodiment,the botanical material disintegrates in the user's mouth.

As used herein, the term “botanical powder” describes dust, fines,colloidal dispersions, granules, dried botanical extract and the likehaving dimensions of less than about 50 mesh, more preferably less thanabout 200 mesh and most preferably less than about 400 mesh. In anembodiment, the soft, chewable and orally dissolvable product 10 canalso include botanical extracts as described above. The botanical powdercan be ground for inclusion in the soft, chewable and orally dissolvableproduct 10 or the botanical powder can be scrap dust and fines too smallfor inclusion in other products. The smaller the botanical powder, theless gritty the soft, chewable and orally dissolvable and/ordisintegrable product may feel in a user's mouth. In addition, the useof smaller botanical powders results in faster disintegration of thepowders.

In the preferred embodiment, the botanical powder is tobacco powder. Forexample, tobacco can be ground to produce a powder for incorporation inthe soft, chewable and orally dissolvable and/or disintegrable product10. Examples of suitable types of tobacco materials that can be used inthe soft, chewable and orally dissolvable product 10 include, but arenot limited to, flue-cured tobacco, air-cured, Burley tobacco, Marylandtobacco, Oriental tobacco, rare tobacco, specialty tobacco, blendsthereof and the like. The tobacco material may be provided in anysuitable form, including, but not limited to, tobacco extract powders,tobacco lamina, processed tobacco materials such as volume expanded orpuffed tobacco, aged tobacco, processed tobacco stems, such ascut-rolled or cut-puffed stems, reconstituted tobacco materials, tobaccoroot, stem and/or stalk material, blends thereof, and the like. Thetobacco may also be genetically modified tobacco or tobacco having areduced tobacco specific nitrosamine (TSNA) content.

In a preferred embodiment, the tobacco can be enzyme treated tobacco,such as, without limitation, the enzyme treated tobacco described inU.S. Pat. Nos. 4,941,484, 4,887,618, 4,307,733, 3,974,838, 3,747,608,4,407,307 and commonly owned U.S. Pat. No. 4,307,733, filed on Dec. 17,1979, the entire contents of which are incorporated herein by reference.

In an embodiment, ground tobacco powder is dispersed in water and thentreated with up to about 5 wt % enzyme, more preferably up to about 4 wt% enzyme by dispersing tobacco powder in water to form a suspension,adding at least one enzyme to the suspension, storing the suspension atabout 45° C. for about 24 hours to about 60 hours to form enzyme treatedtobacco and adding the enzyme treated tobacco to a biopolymer-sugarbased matrix. In a preferred embodiment, the tobacco powder is treatedwith up to about 0.6 wt % enzyme. Suitable enzymes include, withoutlimitation, pectinases, cellulases, hemicellulases, ferulic acidesterase, proteases, lipases and combinations thereof. In an embodiment,commercially available enzyme solutions can be used to treat thetobacco. In a preferred embodiment, the tobacco powder is treated with acombination of enzymes. In an embodiment, the soft, chewable and orallydissolvable and/or disintegrable product can include enzyme treatedtobacco alone or in combination with other types of tobacco and/orbotanical materials.

The following examples of methods of preparing enzyme treating tobaccoand incorporating enzyme treated tobacco in soft, chewable and orallydissolvable and/or disintegrable product are exemplary and are not meantto limit any aspects of the embodiments disclosed herein.

Example 1

About 4 g of tobacco powder having dimensions of less than about 400mesh are dispersed in about 400 ml water at about 45° C. to form asuspension. Less than about 0.6 wt % enzyme is added to the suspension.The suspension is stored at about 45° C. for about 60 hours to completeenzyme treatment. After treatment, a biopolymer binder and sugarco-binder can be added at about 90° C. and cooked for about 20 minutesto form a mixture. The mixture can be gelled at about 4° C. for about 2hours and then dried at about 55° C. for about 12 hours to form a soft,chewable and orally dissolvable and/or disintegrable product includingenzyme treated tobacco.

Example 2

About 4 g of tobacco powder having dimensions of less than about 400mesh are dispersed in about 400 ml water at about 45° C. to form asuspension. Less than about 0.6 wt % enzyme is added to the suspension.The suspension is stored at about 45° C. for about 24 hours to completeenzyme treatment. After treatment, a biopolymer binder and sugarco-binder can be added at about 90° C. and cooked for about 20 minutesto form a mixture. The mixture can be gelled at about 4° C. for about 2hours and then dried at about 55° C. for about 12 hours to form a soft,chewable and orally dissolvable and/or disintegrable product includingenzyme treated tobacco.

Example 3

About 4 g of tobacco powder, including a 1:1 ratio of dark air curedtobacco and stems, having dimensions of less than about 400 mesh aredispersed in about 400 ml water at about 45° C. to form a suspension.Less than about 0.6 wt % enzyme is added to the suspension. Thesuspension is stored at about 45° C. for about 60 hours to completeenzyme treatment. After treatment, a biopolymer binder and sugarco-binder can be added at about 90° C. and cooked for about 20 minutesto form a mixture. The mixture can be gelled at about 4° C. for about 2hours and then dried at about 55° C. for about 12 hours to form a soft,chewable and orally dissolvable and/or disintegrable product includingenzyme treated tobacco.

Not wishing to be bound by theory, it is believed that the use of enzymetreated tobaccos in the soft, chewable and orally dissolvable and/ordisintegrable product 10 may aid in softening and/or modifying thetexture of the soft, chewable and orally dissolvable and/ordisintegrable product because the enzymes used to treat the tobacco arebelieved to break down cell walls of the tobacco. In addition, it isbelieved that the use of enzyme treated tobacco in soft, chewable andorally dissolvable and/or disintegrable product aids in enhancing thetexture of the products, which also have low water activity levels. Theenzyme treatment may also aid in the disintegration of the tobacco is auser's mouth.

In an embodiment, if the soft, chewable and orally dissolvable and/ordisintegrable product 10 includes tobacco powder, the orally dissolvableproduct 10 can also include at least one non-tobacco flavorant. However,soft, chewable and orally dissolvable and/or disintegrable product 10including tobacco powder and/or other botanical powders can also includetobacco based or non-tobacco based flavorants.

Preferably, about 0.01 mg to about 100 mg of a flavorant is added to thesoft, chewable and orally dissolvable and/or disintegrable product 10.The amount of flavorant added can depend on the type and/or potency ofthe flavorant being added, but is preferably added in an amount of up toabout 15 wt %, more preferably up to about 10 wt %. In an embodiment,the soft, chewable and orally dissolvable and/or disintegrable product10 can include multiple flavorants.

For example, a preferred soft, chewable and orally dissolvable and/ordisintegrable product 10 can comprise about 50 wt % tobacco powder,about 20% biopolymer binder, about 20 wt % sugar co-binder, about 3 wt %flavorant and sweeteners and about 7 wt % other additives includingenzymes used to treat the tobacco powder.

In the preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product 10 is formed by first forming a solution ofwater, the biopolymer binder and the sugar co-binder while stirring atabout 90° C. The botanical powder and/or other additives can then beadded to the solution to form a homogenous mixture. Preferably, thebotanical powder does not come into contact with the biopolymer binderbefore the biopolymer binder and sugar co-binder are mixed so as toinhibit cross-linking between the botanical powder and the biopolymerbinder. The mixture can then be cast and allowed to gel at about 4° C.to about 10° C. for about 30 minutes to about 12 hours to form a gel.

Once the gel is formed, the gel can be dried to adjust the watercontent. In a preferred embodiment, the soft, chewable and orallydissolvable and/or disintegrable product 10 also has a low wateractivity of about 0.70 a_(w) to about 0.30 a_(w), and more preferablyless than about 0.60 a_(w). The oven volatiles content of the finalsoft, chewable and orally dissolvable and/or disintegrable product isabout 10 wt % to about 16 wt %. The low water content of the soft,chewable and orally dissolvable and/or disintegrable product 10 protectsagainst microbial growth in the product thereby increasing shelf-life.Preferably, the water content is adjusted by drying the soft, chewableand orally dissolvable and/or disintegrable product after formation asdescribed below.

Preferably, the shelf-life of the soft, chewable and orally dissolvableand/or disintegrable product 10 is at least about 2 weeks, morepreferably at least about 2 months and most preferably at least about 4months (e.g., at least about 6 months). Despite the low moisturecontent, the soft, chewable and orally dissolvable and/or disintegrableproduct could theoretically still suffer from chemical oxidation and/orloss of flavor. Thus, the shelf-life may be increased and/or decreasedbased on the ingredients of the soft, chewable and orally dissolvableand/or disintegrable product and changes therein over time.

Since the soft, chewable and orally dissolvable and/or disintegrableproduct 10 includes a minor amount of water, some hardening may takeplace over time due to drying. However, because the water content is solow, the hardening resulting from drying is substantially unnoticeableto consumers. In other embodiments, additional water can be added toincrease plasticity of the soft, chewable and orally dissolvable and/ordisintegrable product 10 if desired. However, additional water may causenoticeable hardening due to drying and shorter shelf-life.

In the embodiment, the soft, chewable and orally dissolvable and/ordisintegrable product that is formed as described above can be dried atroom temperature for about 1 hours to about 72 hours. In otherembodiments, the gel can be dried in an oven at about 50° C. to about80° C., preferably about 60° C. for about 1 hours to about 72 hours,preferably about 12 hours to about 36 hours.

In a preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product 10 is cut into shapes and/or molded beforeand/or after gelation to form suitably sized, pre-portioned pieces ofsoft, chewable and orally dissolvable and/or disintegrable product 10.In an embodiment, the product can be extruded.

The following are not meant to limit any aspects of the embodimentsdisclosed herein.

Example 4

To form a soft, chewable and orally dissolvable and/or disintegrableproduct containing tobacco powder, up to about 10 wt % GlycerolMonooleate, about 2 wt % to about 20 wt % carrageenan and about 5 wt %to about 30 wt % honey are dissolved in water at about 90° C. whilestirring to form a mixture. Then up to about 10 wt % baking soda and upto about 60 wt % 400 mesh ground tobacco powder is added to the mixture.After homogenous dispersion is obtained, up to about 10 wt % ofadditional flavorant is added. The mixture is then cast on apolyethylene tray. The mixture is then gelled at about 5° C. for about 2hours, and dried at about 60° C. for about 36 hours. The dried sample iscut into desired shapes to form the soft, chewable and orallydissolvable and/or disintegrable product.

In the preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product containing tobacco powder can be placed ina user's mouth and chewed for about 30 seconds to about 40 minutes, morepreferably about 4 minutes to about 8 minutes depending on the size andcomposition. After chewing, the soft, chewable and orally dissolvableand/or disintegrable product dissolves in the mouth.

Also preferably, soft, chewable and orally dissolvable and/ordisintegrable products comprising tobacco powder may have a rubberytexture when chewed, prior to dissolution, as compared to soft, chewableand orally dissolvable and/or disintegrable products comprising otherbotanical powders.

Example 5

To form a soft, chewable and orally dissolvable and/or disintegrableproduct containing tea powder, up to about 10 wt % food gradeemulsifier, up to about 30 wt % carrageenan, up to about 30 wt %modified starch, and up to about 30 wt % honey are dissolved in water atabout 90° C. while stirring to form a mixture. Then, up to about 30 wt %tea extract powder is added to the mixture. After a homogenousdispersion is obtained, up to about 10 wt % of an additional flavorantis added to the mixture. The mixture is then cast on a polyethylenetray. The mixture is gelled at about 5° C. for about 2 hours and thendried at about 60° C. overnight. The dried sample is cut into thedesired shapes to form the soft, chewable and orally dissolvable and/ordisintegrable product.

In a preferred embodiment, soft, chewable and orally dissolvable and/ordisintegrable product 10 including tea powder can be chewed for about 30seconds to about 40 minutes, more preferably about 5 minutes to about 10minutes depending on the size and composition. Also preferably, afterdrying, the water activity is about 0.60 a_(w) to about 0.30 a_(w). Thesoft, chewable and orally dissolvable and/or disintegrable product 10containing tea powder is chewy and/or gummy in texture and dissolves ina user's mouth after chewing.

Example 6

About 2 g pectin and about 4 g honey are dissolved in about 100 ml ofwater at about 95° C. to form a solution. About 5 g tobacco powder isadded to the solution while stirring for about 10 minutes to form asuspension. The suspension is then cast on a sterile polyethylene trayand gelled at about 5° C. for about 2 hours. The gel is then driedovernight at about 40° C. to form a dried gel. The dried gel is then cutinto desired shapes and sizes to form pre-portioned soft, chewable andorally dissolvable and/or disintegrable products.

Example 7

About 2 g gellan gum and about 4 g high fructose corn syrup aredissolved in about 100 ml of water at about 95° C. to form a solution.About 5 g tobacco powder is added to the solution while stirring forabout 10 minutes to form a suspension. The suspension is then cast on asterile polyethylene tray and gelled at about 5° C. for about 2 hours.The gel is then dried overnight at about 40° C. to form a dried gel. Thedried gel is then cut into desired shapes and sizes to formpre-portioned soft, chewable and orally dissolvable and/or disintegrableproducts.

Example 8

About 2 g xanthan gum and about 4 g honey are dissolved in about 100 mlof water at about 95° C. to form a solution. About 5 g tobacco powder isadded to the solution while stirring for about 10 minutes to form asuspension. The suspension is then cast on a sterile polyethylene trayand gelled at about 5° C. for about 2 hours. The gel is then driedovernight at about 40° C. to form a dried gel. The dried gel is then cutinto desired shapes and sizes to form pre-portioned soft, chewable andorally dissolvable and/or disintegrable products.

Example 9

About 2 g modified starch and about 4 g honey are dissolved in about 100ml of water at about 95° C. to form a solution. About 5 g tobacco powderis added to the solution while stirring for about 10 minutes to form asuspension. The suspension is then cast on a sterile polyethylene trayand gelled at about 5° C. for about 2 hours. The gel is then driedovernight at about 40° C. to form a dried gel. The dried gel is then cutinto desired shapes and sizes to form pre-portioned soft, chewable andorally dissolvable and/or disintegrable products.

Example 10

About 2 g xanthan gum and about 4 g honey are dissolved in about 100 mlof water at about 95° C. to form a solution. About 5 g tea powder isadded to the solution while stirring for about 10 minutes to form asuspension. The suspension is then cast on a sterile polyethylene trayand gelled at about 5° C. for about 2 hours. The gel is then driedovernight at about 40° C. to form a dried gel. The dried gel is then cutinto desired shapes and sizes to form pre-portioned soft, chewable andorally dissolvable and/or disintegrable products.

Example 11

About 2 g carrageenan and about 4 g high fructose corn syrup aredissolved in about 100 ml of water at about 95° C. to form a solution.About 5 g tea powder is added to the solution while stirring for about10 minutes to form a suspension. The suspension is then cast on asterile polyethylene tray and gelled at about 5° C. for about 2 hours.The gel is then dried overnight at about 40° C. to form a dried gel. Thedried gel is then cut into desired shapes and sizes to formpre-portioned soft, chewable and orally dissolvable and/or disintegrableproducts.

Example 12

About 2 g pectin and about 4 g honey are dissolved in about 100 ml ofwater at about 95° C. to form a solution. About 5 g tea powder is addedto the solution while stirring for about 10 minutes to form asuspension. The suspension is then cast on a sterile polyethylene trayand gelled at about 5° C. for about 2 hours. The gel is then driedovernight at about 40° C. to form a dried gel. The dried gel is then cutinto desired shapes and sizes to form pre-portioned soft, chewable andorally dissolvable and/or disintegrable products.

Example 13

About 2 g modified starch and about 4 g honey are dissolved in about 100ml of water at about 95° C. to form a solution. About 5 g tea powder isadded to the solution while stirring for about 10 minutes to form asuspension. The suspension is then cast on a sterile polyethylene trayand gelled at about 5° C. for about 2 hours. The gel is then driedovernight at about 40° C. to form a dried sample. The dried gel is thencut into desired shapes and sizes to form pre-portioned soft, chewableand orally dissolvable and/or disintegrable products.

In a preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product 10 is pre-portioned to create individualpieces of the soft, chewable and orally dissolvable and/or disintegrableproduct for packaging and shipping to the consumer. Preferably, eachpre-portioned piece of the soft, chewable and orally dissolvable and/ordisintegrable product 10 is sized and configured to fit comfortably inthe user's mouth. Also preferably, if the soft, chewable and orallydissolvable and/or disintegrable product 10 has edges, the edges aresoft edges. Suitably sized pieces can be packaged individually fordistribution to consumers. Alternatively, multiple pieces can be placedin a single package for distribution to consumers.

The soft, chewable and orally dissolvable and/or disintegrable product10 may be formed in many shapes including, without limitation, spheres,rectangles, oblong shapes, crescent shapes, star shapes, leaf shapes,fruit shapes, ovals, and cubes. The shape of the soft, chewable andorally dissolvable and/or disintegrable product 10 can indicate the typeof botanical powder and/or flavorant included in the soft, chewable andorally dissolvable and/or disintegrable product 10. For example, a tealeaf shape could indicate that tea powder is incorporated in the soft,chewable and orally dissolvable and/or disintegrable product.

In a preferred embodiment, the soft, chewable and orally dissolvableand/or disintegrable product is pre-portioned, rectangular in shape andweighs about 0.5 g to 4.0 g, more preferably about 1.0 g to about 3.0 g.The pre-portioned soft, chewable and orally dissolvable and/ordisintegrable product 10 may be up to about 2 inches long, up to 2inches in height, and up to 2 inches in width. More preferably, thepre-portioned soft, chewable and orally dissolvable and/or disintegrableproduct 10 is up to about 1 inch long, up to about 1 inch in height andup to about 1 inch in width. Most preferably, the pre-portioned soft,chewable and orally dissolvable and/or disintegrable product 10 rangesfrom about 0.1 inch to about 1.5 inch long, about 0.1 inch to about 1.5inch in height and about 0.1 inch to about 1.5 inch in width.

Preferably, the soft, chewable and orally dissolvable and/ordisintegrable product 10 is chewable for about 30 seconds to about 40minutes, more preferably about 3 minutes to about 20 minutes and mostpreferably about 4 minutes to about 10 minutes in a user's mouth. Thechewing time can vary depending on the formulation (e.g., type andamount of botanical powder, biopolymer binder and/or sugar co-binderused) and size of the soft, chewable and orally dissolvable and/ordisintegrable product 10. For example, larger pieces of the soft,chewable and orally dissolvable and/or disintegrable product 10 can bechewed for a longer period of time than smaller pieces of the soft,chewable and orally dissolvable and/or disintegrable product 10. Afterchewing, the soft, chewable and orally dissolvable and/or disintegrableproduct 10 dissolves and/or disintegrates in the user's mouth and isswallowed. In an embodiment, the biopolymer and sugar dissolve and thebotanical powder disintegrates. In other embodiments, all components ofthe product can dissolve and/or disintegrate. In an embodiment, thechewing speeds up dissolution and disintegration in a user's mouth.

In the preferred embodiment, the density of the soft, chewable andorally dissolvable and/or disintegrable product 10 is less than about2.0 g/cm³, more preferably less than about 0.9 g/cm³. In an embodiment,the soft, chewable and orally dissolvable and/or disintegrable product10 can be aerated, if desired, to lower the density of the soft,chewable and orally dissolvable and/or disintegrable product as comparedto non-aerated embodiments of the soft, chewable and orally dissolvableand/or disintegrable product 10.

In another embodiment, as shown in FIGS. 2 and 3 , the soft, chewableand orally dissolvable and/or disintegrable product 10 can comprise abiopolymer-sugar based matrix 14, botanical powder and flavor beads 12.The flavor beads 12 can provide a different texture to the soft,chewable and orally dissolvable and/or disintegrable product 10. Theflavor beads 12 can include encapsulated flavorants, other additivesand/or botanicals. Preferably, the flavor beads 12 include tobacco. Theflavor beads 12 can have a solid, liquid or gel center with a hardexterior coating. The coating can be cross-linked or non-cross-linked,and can include one or more polymers. Preferably, if thebiopolymer-sugar based matrix 14 does not include animal products and/oranimal byproducts, the flavor beads 12 also do not include animalproducts.

In an embodiment, the coating of the flavor beads 12 can be roughened soas to provide an abrasive surface that can rub and/or clean the teethduring chewing.

Preferably, the flavor beads 12 are substantially spherical and havediameters of ranging from about 0.5 mm to about 4.0 mm, more preferablyabout 0.5 mm to about 3.0 mm. Flavor beads 12 included in an individualsoft, chewable and orally dissolvable and/or disintegrable product canhave the same size or an individual soft, chewable and orallydissolvable and/or disintegrable product can include flavor beads ofdifferent sizes.

Also, the flavor beads 12 can be randomly and/or uniformly distributedthroughout the biopolymer-sugar based matrix 14. In an embodiment, theflavor beads 12 can be placed only in the center of the biopolymer-sugarbased matrix 14 or only on the exterior of the biopolymer-sugar basedmatrix 14. In other embodiments, the flavor beads 12 can be arranged ina pattern within the biopolymer-sugar based matrix 14. For example, onethe homogenous mixture is placed in a mold, flavor beads can be arrangedas desired in and/or on the soft, chewable and orally dissolvable and/ordisintegrable product 10.

The flavor beads 12 provide the soft, chewable and orally dissolvableand/or disintegrable product 10 with a crunchy texture when chewed. Inan embodiment, the beads 12 can be popped by mechanical action duringchewing. The mechanical action can aid in the release of the fillingmaterial of the flavor beads 12. Thus, the crunchy texture providesadditional oral activities to the user such that the user can chew, suckand/or crunch the soft, chewable and orally dissolvable and/ordisintegrable product and the flavor beads 12 contained therein.

Alternatively, the flavor beads 12 can dissolve in the user's mouth ifnot popped, such that the filling material of the flavor beads 12 is notreleased until the coating dissolves. In a preferred embodiment, theflavor beads 12 completely disintegrate and/or dissolve after chewingalong with the soft, chewable and orally dissolvable and/ordisintegrable product 10 such that nothing remains in the user's mouthafter use that must be removed and discarded.

Suitable flavor beads 12 can be formed via polysaccharide coating,protein-polysaccharide coacervation, extrusion and/or spheronization,and/or other methods as described below. In an embodiment, tobaccoand/or other botanicals can be encapsulated as in U.S. patentapplication Ser. No. 12/155,227, filed on May 30, 2008, the entirecontent of which is incorporated herein by reference. If tobacco isencapsulated in the beads, the soft, chewable and orally dissolvableand/or disintegrable product 10 can include tobacco in an amount above75 wt %.

In an embodiment, the flavor beads 12 can include controlled releasemechanisms such as pH change, heat activation, or mechanical activationthrough manipulating and/or sucking. In addition, flavor beads 12 canhave encapsulating coatings of various thicknesses so that theflavorants are released at varying rates to provide continuous ordifferent flavor throughout use of the soft, chewable and orallydissolvable and/or disintegrable product 10. In an embodiment, thedissolution time of the matrix 14 and/or flavor beads 12 can be alteredby changing the polysaccharides and mixtures thereof used within thesoft, chewable and orally dissolvable and/or disintegrable product 10.For example, the rate of dissolution can be increased by usingpolysaccharides that are more readily soluble in saliva, while the rateof dissolution can be slowed by using polysaccharides that are lesssoluble in saliva.

In an embodiment, the soft, chewable and orally dissolvable and/ordisintegrable product 10 can include flavor beads 12 of multipleflavorants so that the user is provided with at least two flavors duringconsumption. In addition, when using flavor beads 12 of varying flavorswithin the same soft, chewable and orally dissolvable and/ordisintegrable product 10, the first flavor bead 12 and the second flavorbead 12 may be released by the same or different mechanisms at the sameor different times. Additional flavor beads 12 having the same and/ordifferent flavors may also be used, and may be triggered by differentmethods at different times.

In one embodiment, complimentary flavors beads 12 may be chosen fordifferent time release flavorants to provide a combined flavor. Forinstance, a cherry vanilla flavor may be provided by choosing a cherryflavor bead 12 and a vanilla flavor bead 12. In an embodiment, therelease of flavorants from the cherry flavor bead 12 and the vanillaflavor bead 12 can overlap so that the complimentary flavorants can beenjoyed together.

In addition to providing flavors and texture, the use of flavor beads 12allows for even higher botanical loading in the final soft, chewable andorally dissolvable and/or disintegrable product when the flavor beads 12incorporate botanical materials. Since the botanicals are encapsulated,harsh flavors are avoided as the encapsulated botanicals release thebotanicals over the duration of the chewing time rather than all atonce.

In this specification, the word “about” is often used in connection withnumerical values to indicate that mathematical precision of such valuesis not intended. Accordingly, it is intended that where “about” is usedwith a numerical value, a tolerance of ±10% is contemplated for thatnumerical value.

While the foregoing describes in detail an soft, chewable and orallydissolvable and/or disintegrable product that is chewable, dissolvableand disintegrable in the oral cavity with reference to specificembodiments thereof, it will be apparent to one skilled in the art thatvarious changes and modifications equivalents to the soft, chewable andorally dissolvable and/or disintegrable product and process steps may beemployed, which do not materially depart from the spirit and scope ofthe invention. Accordingly, all such changes, modifications, andequivalents that fall within the spirit and scope of the invention asdefined by the appended claims are intended to be encompassed thereby.

We claim:
 1. A pre-portioned, soft, chewable and orally dissolvableand/or disintegrable product comprising botanical powder distributed ina biopolymer-sugar based matrix, produced by a method comprising:dissolving a biopolymer and a sugar in water to form a solution; addingbotanical powder to the solution; stirring the solution to form asuspension; gelling the suspension to form a gel; drying the gel to forma dried gel; and portioning the dried gel to form a pre-portioned, soft,chewable, and orally dissolvable and/or disintegrabable product, whereinthe botanical powder is distributed in a biopolymer-sugar based matrix.2. The product of claim 1, wherein the biopolymer includes gellan gum,konjac gum, modified starch, pectin, carrageenan, guar gum, xanthan gum,locust bean gum, agar, gum Arabic, alginate, cellulose, or anycombination thereof.
 3. The product of claim 1, comprising, in weightpercent, about 30% to about 75% of the botanical powder, about 1% toabout 35% of the biopolymer, about 2% to about 60% of the sugar and upto about 10% additives.
 4. The product of claim 1, wherein the botanicalpowder includes tobacco powder, coffee powder, tea powder, herb powder,spice powder, cocoa powder, or any combination thereof.
 5. The productof claim 1, wherein the sugar includes monosaccharides includingfructose, glucose and xylose; disaccharides including sucrose, trehaloseand lactose; trisaccharides; polysaccharides; oligosaccharides includingfructan and inulins; sugar alcohols including sorbitol, xylitol,lactitol and maltitol; or any combination thereof.
 6. The product ofclaim 1, wherein the botanical powder has dimensions of less than about50 mesh.
 7. The product of claim 1, wherein the soft, chewable andorally dissolvable and/or disintegrable product is up to about 1 inch inheight, up to about 1 inch in width, and up to about 1 inch in lengthand wherein the soft, chewable and orally dissolvable and/ordisintegrable product has a density of less than about 2.0 g/cm³.
 8. Theproduct of claim 1, wherein the soft, chewable and orally dissolvableand/or disintegrable product ranges in size from about 0.1 inch to about0.5 inch in height, about 0.5 inch to about 1.0 inch in width and about0.25 to about 0.5 inch in length.
 9. The product of claim 1, wherein thesoft, chewable and orally dissolvable and/or disintegrable productfurther comprises (a) at least one vitamin, (b) at least one mineral,(c) at least one nutraceutical, (d) at least one amino acid, (e) atleast one energizing agent, (f) at least one soothing agent, (g) atleast one sweetener, (h) at least one coloring agent, (i) at least onechemesthesis agent, (j) at least one antioxidant, (k) at least onefood-grade emulsifier, (l) at least one pH modifier, or any combinationthereof.
 10. The product of claim 1, wherein the soft, chewable andorally dissolvable and/or disintegrable product has a water activity ofabout 0.70 a_(w) to about 0.30 a_(w).
 11. The product of claim 1,wherein the soft, chewable and orally dissolvable and/or disintegrableproduct has water activity of less than about 0.60 a_(w).
 12. Theproduct of claim 1, wherein the sugar is selected from the groupconsisting of monosaccharides including fructose, glucose and xylose.13. The product of claim 1, wherein the biopolymer includes carrageenan.14. The product of claim 1, wherein the pre-portioned, soft, chewableand orally dissolvable and/or disintegrable product includes about 1 toabout 5 weight % flavor beads comprising a solid, liquid or gel centerand a hard outer coating, the beads having a diameter of about 0.5 mm toabout 4 mm.
 15. The product of claim 14, wherein the pre-portioned,soft, chewable and orally dissolvable and/or disintegrable productincludes a hard outer coating comprising a polymeric coating.
 16. Theproduct of claim 15, wherein the hard outer coating has a rough surface.17. The product of claim 14, wherein the flavor beads are included inthe soft, chewable and orally dissolvable and/or disintegrable productin an amount of about 1 weight % to about 5 weight % based on the weightof the soft, chewable and orally dissolvable and/or disintegrableproduct.
 18. The product of claim 14, wherein the flavor beads arecontained in a center of the soft, chewable and orally dissolvableand/or disintegrable product, on an exterior of the soft, chewable andorally dissolvable and/or disintegrable product, or both.
 19. A soft,chewable and orally dissolvable and/or disintegrable product comprisingenzyme treated tobacco powder, a biopolymer, and a sugar, produced by amethod comprising: dissolving a biopolymer and a sugar in water for forma solution; adding botanical powder to the solution; stirring thesolution to form a suspension; gelling the suspension to form a gel;drying the gel to form a dried gel; and portioning the dried gel to forma pre-portioned, soft, chewable, and orally dissolvable and/ordisintegrable product, wherein the botanical powder is distributed in abiopolymer-sugar based matrix and wherein the botanical powder is anenzyme treated tobacco powder.
 20. The product of claim 19, wherein theenzyme includes pectinases, cellulases, hemicellulases, ferulic acidesterase, proteases, lipases, or any combination thereof.